BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2191014 · Received July 19, 2011

    Report

    Report Number
    2023826-2011-00650
    Event Type
    Malfunction
    Date Received
    July 19, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 23, 2011
    Manufacturer
    STAAR SURGICAL CO.
    Product Code
    MTA
    PMA / PMN Number
    P[030016
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THE SURGEON PARTIALLY INSERTED A MICL 12.6MM IMPLANTABLE COLLAMER LENS. UPON INJECTING, THE LENS DID NOT GO ALL THE WAY INTO THE EYE, ONLY PARTIALLY INSERTED. SOME DEBRIS GOT ON THE LENS AND THE SURGEON REMOVED. THERE WAS NO PATIENT INJURY. ANOTHER SAME MODEL AND SIZE LENS WAS IMPLANTED. REPORTER STATED THERE WAS NO PRODUCT MALFUNCTION. THIS INCIDENT WAS DUE TO SURGEON ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL CO. MICL12.6 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR INJECTOR: MODEL MSI-PF, LOT NUMBER UNK| CARTRIDGE: MODEL SFC-45 FP, LOT NUMBER UNK| FOAM TIP PLUNGER: MODEL, LOT NUMBER UNK